BioTritis 2120SS

GUDID 10884521513358

Bio Absorbable ACL Tibial Fixation System, Graft Cleat, Fixation Screw, 8 mm Fixation Washer and Trocar Tip Drill/Drill Guide

Covidien LP

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• Primary Device ID: 10884521513358
• NIH Device Record Key: e0ac3973-3257-41ce-bbe4-ee49bd3cc835
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioTritis
• Version Model Number: 2120SS
• Catalog Number: 2120SS
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Width: 9 Millimeter
• Length: 30 Millimeter
• Width: 9 Millimeter
• Length: 30 Millimeter
• Width: 9 Millimeter
• Length: 30 Millimeter
• Width: 9 Millimeter
• Length: 30 Millimeter
• Width: 9 Millimeter
• Length: 30 Millimeter
• Width: 9 Millimeter
• Length: 30 Millimeter
• Width: 9 Millimeter
• Length: 30 Millimeter
• Width: 9 Millimeter
• Length: 30 Millimeter
• Width: 9 Millimeter
• Length: 30 Millimeter
• Width: 9 Millimeter
• Length: 30 Millimeter
• Width: 9 Millimeter
• Length: 30 Millimeter
• Width: 9 Millimeter
• Length: 30 Millimeter
• Width: 9 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521513358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060522

FDA Product Code

• MAI: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-01
• Device Publish Date: 2016-09-24

On-Brand Devices [BioTritis]

• 10884521513532: Bio Absorbable ACL Tibial Fixation System, Graft Cleat, Fixation Screw, 10 mm Fixation Washer an
• 10884521513495: Bio Absorbable ACL Tibial Fixation System
• 10884521513471: Bio Absorbable ACL Tibial Fixation System, Graft Cleat, Fixation Screw, 10 mm Fixation Washer an
• 10884521513457: Bio Absorbable ACL Tibial Fixation System, Graft Cleat, Fixation Screw, 8 mm Fixation Washer and
• 10884521513358: Bio Absorbable ACL Tibial Fixation System, Graft Cleat, Fixation Screw, 8 mm Fixation Washer and
• 10884521513341: Bio Absorbable ACL Tibial Fixation System, Graft Cleat, Fixation Screw, 8 mm Fixation Washer and
• 10884521513334: Bio Absorbable ACL Tibial Fixation System, Graft Cleat, Fixation Screw, 8 mm Fixation Washer and